Medical system and method of manufacturing thereof

ABSTRACT

An inventive medical system has a housing with a first guiding surface. A preassembled module is received in the housing. The module includes electronics electrically connected to an analytical sensor, an insertion component configured for inserting the analytical sensor into body tissue of a user and a sterility cap at least partially surrounding the insertion component. The module has a second guiding surface. A protective cap is removably connected to the housing and covers the preassembled module. The protective cap is removable from the housing by pulling the protective cap from the housing. The first guiding surface guides the protective cap during the pulling of the protective cap from the housing and the second guiding surface guides the sterility cap during pulling the sterility cap from the insertion component. The length of the first guiding surface exceeds the length of the second guiding surface.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/898,049, filed Jun. 10, 2020, which is a continuation ofInternational Application Serial No. PCT/EP2018/086139, filed Dec. 20,2018, which claims priority to EP 17 209 756.0, filed Dec. 21, 2017, theentire disclosures of all of which are hereby incorporated herein byreference.

BACKGROUND

This disclosure relates to a medical system and to a method ofmanufacturing a medical system. The medical system specifically may beused for detecting at least one analyte in a body fluid, such as a bodyfluid contained in a body tissue. The medical system specifically may beused for inserting an analyte sensor contained in the system into thebody tissue of the user. The medical system may be applied both in thefield of home care and in the field of professional care, such as inhospitals. Other applications are feasible.

Monitoring certain body functions, more particularly, monitoring one ormore concentrations of at least one analyte concentration such as atleast one metabolite concentration in a body fluid, plays an importantrole in the prevention and treatment of various diseases. Such analytescan include by way of example, but not exclusively, blood glucose,lactate, cholesterol or other types of analytes and metabolites. Withoutrestricting further possible applications, this disclosure will bedescribed in the following text with reference to blood-glucosemonitoring. However, additionally or alternatively, this disclosure canalso be applied to other types of analytes, such as the analytesmentioned above.

For monitoring these body functions, specifically for monitoring theconcentration of at least one analyte, over a period of time,specifically, electrochemical sensors are used which transcutaneouslyare inserted into the body tissue of the user. The sensors typicallycomprise an elongated flexible substrate onto which a plurality ofelectrodes, including one or more working electrodes and one or morefurther electrodes such as one or more counter electrodes and/or one ormore reference electrodes are applied.

As an example, U.S. Publication No. 2010/0200538 A1 discloses methodsfor fabricating analyte sensor components, using IC- or MEMs-basedfabrication techniques and sensors prepared therefrom. Fabrication ofthe analyte sensor component comprises providing an inorganic substratehaving deposited thereon a release layer, a first flexible dielectriclayer and a second flexible dielectric layer insulating there betweenelectrodes, contact pads and traces connecting the electrodes and thecontact pads of a plurality of sensors. Openings are provided in one ofthe dielectric layers over one or more of the electrodes to receive ananalyte sensing membrane for the detection of an analyte of interest andfor electrical connection with external electronics. The plurality offabricated sensor components are lifted off the inorganic substrate.

As a further example, EP 2348964 B1 discloses an electrode system formeasuring the concentration of an analyte under in-vivo conditions. Theelectrode system comprises a counter-electrode having an electricalconductor, a working electrode having an electrical conductor on whichan enzyme layer containing immobilized enzyme molecules for catalyticconversion of the analyte is arranged, and a diffusion barrier thatslows the diffusion of the analyte from body fluid surrounding theelectrode system to enzyme molecules down. The invention provides theenzyme layer in the form of multiple fields that are arranged on theconductor of the working electrode at a distance from each other.

Several challenges in the field of continuous monitoring systems have tobe addressed. One challenge resides in appropriate devices for insertingthe analyte sensor into the body tissue. A further challenge resides inthe fact that, in many systems, the analyte sensor has to beelectrically connected to an electronics unit disposed on the surface ofthe skin of the user. Further challenges reside in the overall handlingof the medical system which, in many cases, has to be performed byuntrained users including children and elderly people, which generallyrequires easy handling procedures with as little steps as possible.

WO 2016/012482 A1 discloses an insertion device for inserting an analytesensor into a body tissue, the insertion device having an insertionneedle holder and a drive mechanism for linearly driving the insertionneedle holder in a longitudinal direction. The drive mechanism comprisesat least one actuator for actuating the drive mechanism. The actuatorcomprises at least one actuator arm which is pivotable about at leastone axle in order to actuate the drive mechanism. The insertion devicefurther comprises at least one protection against reuse including atleast one locking mechanism. The locking mechanism is adapted to atleast partially prevent a back-pivoting of the actuator arm in adirection reversing the actuation direction once the actuator arm hasbeen pivoted by at least one threshold angle.

Similarly, WO 2016/012497 A1 discloses an insertion device for insertingan analyte sensor into a body tissue. The insertion device comprises aninsertion needle holder and a drive mechanism for driving the insertionneedle holder in a longitudinal direction. The drive mechanism comprisesat least one actuator for actuating the drive mechanism. The drivemechanism comprises a rotor adapted to transform an actuation motion ofthe actuator into a motion of the insertion needle holder in thelongitudinal direction. The insertion device further comprises at leastone safety lock. The safety lock, in a locked position, is adapted to atleast partially block a rotation of the rotor. In an unlocked position,the safety lock is adapted to permit the rotation of the rotor.

Further, disposable systems for long-term monitoring of an analyte aswell as corresponding insertion devices for analyte sensors are known.WO 2017/037191 A1 discloses a kit for determining a concentration of atleast one analyte in a body fluid of a user, comprising: a) a sensormodule comprising i. at least one sensor element adapted to determinethe concentration of the analyte, wherein the sensor element is at leastpartly implantable into a body tissue of the user; ii. at least onecontrol device connected to the sensor element, wherein the controldevice comprises at least one data collection device adapted to collectmeasurement data acquired by using the sensor element, wherein thecontrol device further comprises at least one wireless near-fieldcommunication device adapted to transmit measurement data, wherein thesensor module comprises a sensor module mechanical interface; b) atleast one data reader module adapted to receive measurement datatransmitted by the sensor module via wireless near-field communication,wherein the data reader module comprises at least one data storagedevice and is adapted to store the measurement data; c) at least onedata transmission module adapted to receive measurement data transmittedby the sensor module via wireless near-field communication, wherein thedata transmission module comprises at least one wireless far-fieldcommunication device, wherein the wireless far-field communicationdevice is adapted to transmit at least part of the measurement data toan external device via wireless far-field communication. The data readermodule and the data transmission module each comprise a mechanicalinterface adapted to reversibly engage the sensor module mechanicalinterface, thereby alternatively generating a fixed spatial relationshipbetween the sensor module and the data reader module or the sensormodule and the data transmission module.

Further, in EP 2 991 552 A1 systems, devices, and methods are describedfor changing the power state of a sensor control device in an in vivoanalyte monitoring system in various manners, such as through the use ofexternal stimuli (light, magnetics) and RF transmissions.

WO 2011/119896 A1 describes an apparatus for insertion of a medicaldevice in the skin of a subject, as well as methods of inserting medicaldevices. Said apparatus includes a sheath, a device support movablebetween a proximal and distal position, a sharp support movable betweena proximal and distal position, a handle movable between a proximal anddistal position, and a driver.

U. S. Publication No. 2010/0286714 A1 describes an inserter device forinserting a medical device into the subcutaneous or intramuscular areaof a patient. More specifically, an inserter device is describedcomprising means for providing a controlled and defined acceleration anddeceleration of a penetrating member. The inserter device according tothe invention comprises a housing (encompassing said penetrating member,a rotating member and driving means for rotating the rotating memberaround a rotating axis. The rotating member comprises transformationmeans transforming the rotational movement into a longitudinal movementof the penetrating member in the direction of insertion and thetransformation means comprises controlling means providing a controlledvariation of the velocity of the penetrating member in the direction ofinsertion.

U.S. Publication No. 2007/0202488 A1 describes method for determiningthe relative benefits of products which affect animal epithelial tissue.Also provided is a method for evaluating quantitative changes on one ormore affected surfaces of epithelial tissue of a subject caused by atest product.

U.S. Publication No. 2016/0331284 A1 describes compact medical deviceinserters, systems incorporating the same, and related methods of use.The inserters can include a housing, a sharp support, a sharp body, anda shroud, and can apply a sensor control device to a recipient with asensor implanted in the recipient's body. The shroud can extend from thesensor control device in a position that covers or protects the sensorand a sharp, and can be retracted by pressure placed upon the inserteragainst the recipient's body to cause the sharp and sensor to penetratethe body, after which the sharp can be automatically withdrawn with theaid of a biasing element.

Despite the advantages achieved by the above-mentioned devices, severaltechnical challenges remain. Specifically, reliably connecting theanalyte sensor to the electronics unit remains a challenge. Further, thetrend for miniaturization generally encourages the use of disposableelectronics, with a battery included. These devices, however, generallyshould be switched off during storage and transport and should beswitched on after insertion of the analyte sensor into the body tissue.The switching, however, generally requires an additional step to beperformed by the user. Further, protecting the analyte sensor and theelectronics during storage, transport and use, specifically againsthumidity and mechanical shocks, remains to be an issue. It is thereforedesirable to provide devices and methods which address theabove-mentioned technical challenges.

SUMMARY

A medical system is disclosed which allows easy and user-friendlyinsertion of an analyte sensor into a body tissue, with few handlingsteps and with a high degree of protection against detrimentalmechanical and environmental influences.

As used in the following, the terms “have,” “comprise” or “include” orany arbitrary grammatical variations thereof are used in a non-exclusiveway. Thus, these terms may both refer to a situation in which, besidesthe feature introduced by these terms, no further features are presentin the entity described in this context and to a situation in which oneor more further features are present. As an example, the expressions “Ahas B,” “A comprises B” and “A includes B” may both refer to a situationin which, besides B, no other element is present in A (i.e., a situationin which A solely and exclusively consists of B) and to a situation inwhich, besides B, one or more further elements are present in entity A,such as element C, elements C and D or even further elements.

Further, it shall be noted that the terms “at least one,” “one or more”or similar expressions indicating that a feature or element may bepresent once or more than once typically will be used only once whenintroducing the respective feature or element. In the following, in mostcases, when referring to the respective feature or element, theexpressions “at least one” or “one or more” will not be repeated,non-withstanding the fact that the respective feature or element may bepresent once or more than once. It shall also be understood for purposesof this disclosure and appended claims that, regardless of whether thephrases “one or more” or “at least one” precede an element or featureappearing in this disclosure or claims, such element or feature shallnot receive a singular interpretation unless it is made explicit herein.By way of non-limiting example, the terms “protective cap,” “sterilitycap,” and “guiding surface,” to name just a few, should be interpretedwherever they appear in this disclosure and claims to mean “at leastone” or “one or more” regardless of whether they are introduced with theexpressions “at least one” or “one or more.” All other terms used hereinshould be similarly interpreted unless it is made explicit that asingular interpretation is intended.

Further, as used in the following, the terms “preferably,” “morepreferably,” “particularly,” “more particularly,” “specifically,” “morespecifically” or similar terms are used in conjunction with optionalfeatures, without restricting alternative possibilities. Thus, featuresintroduced by these terms are optional features and are not intended torestrict the scope of the claims in any way. The invention may, as theskilled person will recognize, be performed by using alternativefeatures. Similarly, features introduced by “in an embodiment of theinvention” or similar expressions are intended to be optional features,without any restriction regarding alternative embodiments of theinvention, without any restrictions regarding the scope of the inventionand without any restriction regarding the possibility of combining thefeatures introduced in such way with other optional or non-optionalfeatures of the invention.

In a first aspect of this disclosure, a medical system is disclosed. Thesystem specifically may be configured for and used for qualitativelyand/or quantitatively detecting at least one analyte in a body fluid,such as one or more of the analyte listed above.

The medical system comprises:

-   -   a. a housing;    -   b. a preassembled functional module received in the housing, the        preassembled functional module comprising        -   b1. an analytical sensor for detecting at least one analyte            in a body fluid of a user;        -   b2. an electronics unit electrically connected to the            analytical sensor; and        -   b3. an insertion component for inserting the analytical            sensor into a body tissue of the user; and    -   c. at least one removable protective cap connected to the        housing, covering the preassembled functional module.

Components a., b., and c. as listed above specifically may bepre-assembled, such as to form a pre-assembled module, a pre-assembledsingle unit, a single factory-assembled module. This pre-assembledmodule or unit, specifically, may be packaged, as will be outlined infurther detail below, e.g., in a blister pack.

The term “medical system” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art and is not to be limited to a special or customized meaning.The term specifically may refer, without limitation, to a systemconfigured for performing at least one medical function. Specifically,as outlined above, the medical system may be configured forqualitatively and/or quantitatively detecting at least one analyte in abody fluid, such as in a body fluid contained in a body tissue of auser. The medical system specifically may be configured for performingat least two actions, which are the action of inserting an analyticalsensor into the body tissue and to the action of detecting the analytein the body fluid by using the analytical sensor. The medical systemspecifically may be, in a basic state before use, a unitary system whichmay be handled as one single piece. After use, which is after insertionof the analyte sensor into the body tissue, the medical system maydisassemble into a disposable handling component including an inserterin a used state, and into an analyte sensor unit, with a body mount andthe analyte sensor, wherein the body mount may be attached to the skinof the user and wherein the analyte sensor may protrude from the analytesensor unit into the body tissue.

As further used herein, the term “housing” is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art and is not to be limited to a special or customized meaning.The term specifically may refer, without limitation, to a basicallyarbitrary element which is configured for fully or partially enclosingone or more components and for providing protection for these one ormore components, such as against mechanical influence and/or humidity.The housing, specifically, may be or may comprise a rigid housing, suchas a rigid housing made of one or more of a plastic material, a metallicmaterial or a cardboard material. The housing may have a front facewhich is configured for being disposed on the skin of the user, such asan essentially flat front face. The front face, as an example, may havea rim, with an opening enclosed by the rim, wherein the rim, as anexample, is configured for tightening the skin for application of theanalyte sensor. The housing, as will be explained in further detailbelow, may comprise, may contain or may encase one or more furthercomponents, such as an insertion actuator.

As further used herein, the term “functional module” (also referred toherein as “module”) is a broad term and is to be given its ordinary andcustomary meaning to a person of ordinary skill in the art and is not tobe limited to a special or customized meaning. The term specifically mayrefer, without limitation, to a module, such as a unitary module made ofone or more components, specifically a plurality of interconnectedcomponents, which are configured for interacting for performing at leastone function, specifically at least one medical function. In the presentcase, the functional module specifically may be a medical functionalmodule configured for performing at least one medical function, such asfor qualitatively and/or quantitatively detecting at least one analytein a body fluid.

As further used herein, the term “preassembled” generally refers to thefact that an assembly process has already taken place. Thus, a“preassembled” medical system comprises the functional module as definedabove in a preassembled state, which means the components of thefunctional module already being assembled, such as by being mechanicallyand/or electrically interconnected, thereby being ready for use for theat least one function, such as the at least one medical function, e.g.,for the at least one analytical function. The pre-assemblingspecifically may take place in a factory, thereby rendering thepreassembled functional module a factory-assembled functional module.Specifically, the medical system may be configured such that the atleast one preassembled functional module is fully covered by thecombination of the housing and the protective cap, such that the usermay not see or manipulate the preassembled functional module withoutopening the medical device, e.g., without removing the protective cap.

As further used herein, the term “received in the housing” generallyrefers to the fact that the preassembled functional module is fully orpartially surrounded by the housing. As outlined above, specifically,the housing may comprise at least one receptacle for receiving thepreassembled functional module. The receptacle, as an example, may belocated in a front face of the housing, wherein the receptacle may fullyor partially be surrounded by a frame formed, e.g., by the housing. Thereceptacle may be covered by the protective cap, such that, when theprotective cap is removed from the housing, the functional module isaccessible and may be placed on the skin of the user.

The term “sensor” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the artand is not to be limited to a special or customized meaning. The termspecifically may refer, without limitation, to an arbitrary element ordevice configured for detecting at least one condition or for measuringat least one measurement variable. The sensor specifically may be or maycomprise an analyte sensor for at least partial implantation into a bodytissue of a user, more specifically an analyte sensor for continuousmonitoring of the analyte. The sensor specifically may be a monolithicsensor element.

Consequently and as further used herein, the term “analytical sensor” isa broad term and is to be given its ordinary and customary meaning to aperson of ordinary skill in the art and is not to be limited to aspecial or customized meaning. The term specifically may refer, withoutlimitation, to a sensor according to the definition given above, whichis configured for being used for analytical purposes. Specifically, theanalytical sensor may be configured for qualitatively and/orquantitatively detecting at least one analyte in a body fluid of theuser, such as one or more of the analytes listed above, morespecifically glucose. The body fluid, as an example, may be or maycontain one or more of blood or interstitial fluid. The analyticalsensor specifically may be configured for long-term monitoring of theanalyte. The analytical sensor, as an example, may be configured forbeing placed into the body tissue and for remaining therein for at leastone week, by providing measurement data over this period of use. Theanalytical sensor specifically may be or may comprise an electrochemicalanalytical sensor, as will be described in further detail below.

The term “electronics unit” (also referred to as “electronics” or“electronics assembly”) as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art and is not to be limited to a special or customized meaning.The term specifically may refer, without limitation, to a unit, such asa unit which may be handled as a single piece, which is configured forperforming at least one electronic function. Specifically, theelectronics unit may have at least one interface for being connected tothe analytical sensor, wherein the electronics unit may provide at leastone electronic function interacting with the analytical sensor, such asat least one measurement function. As will be outlined in further detailbelow, the electronics unit specifically may be configured for measuringat least one voltage and/or for measuring at least one current, therebyinteracting with the analytical sensor, specifically the electrochemicalanalytical sensor. The electronics unit specifically may comprise atleast one electronics unit housing, wherein the analytical sensor, e.g.,with a proximal end, may protrude into the housing and may beelectrically connected with at least one electronic component within thehousing. As an example, the proximal end and/or at least one contactportion of the electrochemical sensor may protrude into the housing and,therein, may be electrically connected to at least one electroniccomponent, such as to at least one printed circuit board and/or at leastone contact portion of the electronics unit, e.g., by one or more of asoldering connection, a bonding connection, a plug, a clampingconnection or the like. The electronics unit, as will be outlined infurther detail below, specifically may be used as a transmitter fortransmitting measurement data to at least one external device, such asto at least one receiver, e.g., wirelessly.

The electronics unit is electrically connected to the analytical sensor.Thus, an electrical connection exists between the analytical sensor andthe electronics unit. Via this electrical connection, the electronicsunit may interact with the analytical sensor for performing at least oneelectrochemical measurement. The electrical connection specifically, asoutlined above, may be established by at least one connection portion ofthe analytical sensor protruding into a housing of the electronics unit.The functional module may be preassembled in the sense that, theelectronics unit is already electrically connected to the analyticalsensor when the functional module is received in the housing, with theprotective cap being connected to the housing. Specifically, theelectronics unit may be irreversibly electrically connected to theanalytical sensor. Thus, specifically, no need for assembly of theelectronics unit and the analytical sensor is given, since, in thepreassembled functional module, the electronics unit and the analyticalsensor are already connected, electrically and optionally alsomechanically.

The term “insertion component” (also referred to herein as an“inserter”) as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the artand is not to be limited to a special or customized meaning. The termspecifically may refer, without limitation, to an element or acombination of elements which are configured for inserting at least onecomponent into a body tissue of a user, e.g., transcutaneously orsubcutaneously. Thus, specifically, the at least one insertion componentmay be or may comprise at least one insertion cannula, with a tip orsharp configured for piercing the skin of the user and further,optionally, with at least one slot configured for receiving at least apart of the analytical sensor. The insertion component may comprisefurther elements, such as at least one holder for manipulating orholding the insertion component such as the insertion cannula.

The electronics unit specifically may have an opening there through,through which the insertion component may protrude. Thus, as an example,the electronics unit may have an upper side and a lower side, with thelower side facing towards the skin of the user and with the upper sidefacing towards the housing, such as towards an insertion actuator. Theinsertion actuator may drive the insertion component, such as theinsertion cannula, through the opening, such as through a through holein in a housing of the electronics unit.

The term “protective cap” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art and is not to be limited to a special or customized meaning.The term specifically may refer, without limitation, to an elementconfigured for partially covering at least one other device, componentor element, thereby providing at least partial protection againstmechanical and/or environmental influences. The protective capspecifically may be fully or partially made of at least one rigidmaterial, such as of at least one plastic material and/or at least onemetal. The protective cap specifically may have an opening which isconfigured to be directed towards the housing of the medical system. Theprotective cap specifically may be made essentially rotationallysymmetric, e.g., by having an axial rotational symmetry about an axissuch as a cylinder axis. The protective cap, as an example, may bedesigned as a cylinder, a hemisphere or as a dome.

The protective cap, as an example, may be connected to the housing by atleast one of a form-fit or a force-fit connection. Specifically, a rimof the protective cap may be pushed over a rim of the housing or viceversa. Thus, as an example, the protective cap may have a circular, ovalor polygonal rim which fits tightly over the rim of the housing having acorresponding shape, or vice versa. There may be an overlap region inthe connected state, in which the protective cap overlaps with thehousing or vice versa.

As outlined above, the housing specifically may comprise at least onereceptacle for receiving the electronics unit, the receptacle being opentowards an end of the housing covered by the protective cap. Therein, asan example, the receptacle may comprise at least one open space, beingopen towards the front face of the housing, wherein the electronics unitis received within the open space. The electronics unit may be held inthe receptacle by at least one holding means, such as by at least onehook or the like, which may free the electronics unit once applied tothe skin of the user, e.g., after insertion of the analytical sensorinto the body tissue.

As outlined above, the electronics unit specifically may comprise atleast one electronics component. Specifically, the electronics unit maycomprise at least one of: a measurement device for providingelectrochemical measurement values, specifically at least one of anamperometric or a potentiostatic measurement device; a transmitter fortransmitting measurement values to at least one external receiver; anintegrated data storage device; an integrated battery. These electroniccomponents generally are known in the art of long-term monitoring one ormore analytes, such as in from one or more of the above-mentioned priorart documents.

As outlined above, specifically in an assembled state of the analyticalsystem and prior to removal of the protective cap, the analytical sensoris fixedly electrically connected to the electronics unit. Thus, asopposed to systems in which the analytical sensor is connected to anelectronics unit during insertion, in the present case, the analyticalsensor specifically may be electrically connected to electronics unitprior to insertion. Thus, the analytical sensor and the electronics unitmay form part of a disposable unit.

The analytical sensor specifically may be an electrochemical analyticalsensor. Thus, the electrochemical analytical sensor specifically mayhave at least one working electrode and at least one further electrodeselected from the group consisting of a counter electrode and areference electrode. As an example, the at least one working electrodemay comprise at least one chemical reagent for detecting the at leastone analyte, such as at least one chemical reagent containing at leastone enzyme. The at least one working electrode and the at least onefurther electrode specifically may be connected to the electronics unitvia at least two electrical leads.

The preassembled functional module may further comprise at least onesterility cap at least partially surrounding the insertion component.

The term “sterility cap” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art and is not to be limited to a special or customized meaning.The term specifically may refer, without limitation, to an element suchas a cover which is configured for maintaining a sterile atmosphere in aspace fully or partially surrounded by the element. The sterility cap,as an example, may be a rigid sterility cap, e.g., made of a rigidplastic material and/or a metal. The sterility cap, as an example, mayhave a rotational symmetry about an axis which, as an example, may beidentical to a rotational symmetry axis of the protective cap and/or ofa rotational symmetry axis of the housing. The sterility cap, as anexample, may have an elongated shape, with a length exceeding itsdiameter or equivalent diameter by at least a factor of 2, morepreferably by at least a factor of five. The sterility cap, as anexample, may have a length of 5 to 20 mm, e.g., a length of 10 to 15 mm.

As outlined above, the insertion component specifically may comprise atleast one insertion cannula. The insertion cannula may fully orpartially be received in the sterility cap. The sterility cap, as anexample, may have an elongated shape, with a closed end and an open end,with the insertion cannula protruding from the open end into thesterility cap, with the tip of the insertion cannula facing the closedend. The analytical sensor may partially be received in the insertioncannula, such as in a slot of the insertion cannula. The insertioncomponent may further comprise at least one holder for the insertioncannula, wherein the holder, the insertion cannula and the sterility capform components of a sterile container for the analytical sensor. Theholder, as an example, may comprise a rigid component connected to aproximal end of the insertion cannula, i.e., to an end of the insertioncannula opposing the tip of the insertion cannula. The insertioncannula, as an example, may be connected to the holder by gluing and/orby injection molding and/or, e.g., by other means of materialengagement. The holder, as an example, may have a cylindrical shape.

The protective cap specifically may be removable from the housing bypulling off the protective cap from the housing. Thus, as outlinedabove, the protective cap may, in a stage connected to the housing,overlap with the housing or vice versa. The protective cap specificallymay be stuck onto the housing in a tight fashion. The housingspecifically may comprise at least one guiding surface for guiding theprotective cap during pulling off the protective cap, specifically acircumferential guiding surface. Thus, the guiding surface may be anouter surface of the housing, such as an outer surface having one of acircular cross-section, and oval cross-section or a polygonalcross-section. In the connected state, the protective cap may overlapwith the housing within the guiding surface. When being pulled off fromthe housing, the protective cap, such as an inner surface of theprotective cap, may slide over the guiding surface.

The sterility cap specifically may be fixedly connected to theprotective cap. Thus, the sterility cap may be configured for beingpulled off from the insertion component when the protective cap ispulled off from the housing. Still, the sterility cap may be distinctfrom the protective cap. Thus, even though the sterility cap may bereceived within the protective cap, the wall of the sterility cap shouldbe different from the wall of the protective cap. The sterility cap,however, may be connected to the protective cap at a distal end of thesterility cap, e.g., by one or more of a form-fit connection, aforce-fit connection or a connection by material engagement such as agluing or a connection by injection molding. The protective cap and thesterility cap specifically may be made of different materials.

The option of connecting the action of removing the protective cap fromthe housing with the action of pulling off the sterility cap from theinsertion component provides a plurality of further options andadvantages. Thus, as an example, the preassembled functional module maycomprise at least one guiding surface for guiding the sterility capduring pulling off the sterility cap from the insertion component. Alength of the guiding surface of the housing may exceed a length of theguiding surface for the sterility cap, specifically by at least a factorof 2, more specifically by at least a factor of 5 or by at least afactor of 10. Additionally or alternatively, a length of the guidingsurface of the housing may exceed a length of the sterility cap,specifically such that the sterility cap is fully pulled off from theinsertion component before the guiding by the guiding surface of thehousing ends when the protective cap is pulled off from the housing.Thus, in other words, by coupling the action of removing the protectivecap from the housing, e.g., by pulling off the protective cap from thehousing, with the action of removing the sterility cap from theinsertion component, e.g., from the insertion cannula, provides theoption of guiding the sterility cap via guiding the protective cap bythe housing, such that the sterility cap performs a well-definedmovement until the insertion component, e.g., the insertion cannula, isfully free and until the sterility cap is fully removed from theinsertion component. Thus, the risk of mechanically damaging theinsertion component, e.g., the insertion cannula, during removal of thesterility cap may be significantly reduced, since the movement of thesterility cap is well-defined and may be directed precisely along alongitudinal axis of the insertion component, e.g., the insertioncannula, specifically over the full length of the insertion cannula.

The guiding surface of the housing specifically may provide for at leastone movement selected from the group consisting of: a translationalmovement of the protective cap and the sterility cap when the protectivecap is pulled off from the housing; a rotational movement of theprotective cap and the sterility cap when the protective cap is pulledoff from the housing; both a translational and a rotational movement ofthe protective cap and the sterility cap when the protective cap ispulled off from the housing. Thus, several movements are possible andmay even be combined. As an example, when pulling off the protectivecap, the protective cap may only perform a translational movement, e.g.,along a longitudinal axis of the medical system. However, rotationalmovements may be introduced additionally or alternatively. As anexample, the at least one guiding surface may provide for one or morespiral-shaped guiding elements or guiding surfaces, thereby introducinga rotational movement. The rotational movement specifically may also beused for blocking or unlocking actions. Thus, as an example, the guidingsurface of the housing may provide at least a rotational component whenthe protective cap is pulled off from the housing. The sterility cap maybe connected to the preassembled functional module by at least onebayonet connection, wherein, by the rotational component, the bayonetconnection may be untightened and the sterility cap may be removablefrom the preassembled functional module.

The medical system may further comprise at least one indicator sealconnected to the protective cap and the housing. As used herein, theterm “indicator seal” specifically may refer to an element which isvisible to a user and which indicates whether the medical system hasbeen used before, specifically whether the protective cap has alreadybeen removed from the housing before. Thus, the indicator seal may alsobe referred to as an originality seal. The medical system may compriseone or more tamper-evident closure means and the indicator seal may bepart of the tamper-evident closure means. The indicator seal, as anexample, may be configured to be broken when the protective cap isremoved from the housing. The indicator seal specifically may compriseone of a sealing foil and a sealing tape. The indicator seal mayexemplarily be an originality closure.

The indicator seal may provide further functionality to the medicalsystem. Thus, the indicator seal may also provide sealing properties,such as against ingression of humidity into the housing and/or into theprotective cap. Additionally or alternatively, the indicator seal may belight-tight. This option is specifically useful in connection with theoption of the electronics unit being activated by an optical switch,which will be explained in further detail below.

Thus, generally, the medical system may be configured such that theelectronics unit is switched on when the protective cap is removed fromthe housing. The electronics unit specifically may be switched on by atleast one switching mechanism selected from the group consisting of: amechanical switch connected to the cap, wherein the mechanical switch isswitched on when the protective cap is removed from the housing; alight-sensitive switch, wherein the light-sensitive switch is switchedon by ambient light when the protective cap is removed from the housing;a liner covering a battery of the electronics unit, wherein the liner ispulled off when the protective cap is removed from the housing. Thus, asan example, the protective cap may comprise a pin or a ribbon which isconnected to the electronics unit. By removing the protective cap, e.g.,by pulling off the protective cap, the pin or the ribbon may set free aswitch within the electronics unit, thereby switching on the electronicsunit. Additionally or alternatively, the electronics unit may comprise aphotodiode, a phototransistor or another light-sensitive element whichis configured for detecting the removal of the protective cap andambient light shining on to the electronics unit, the electronics unitbeing configured for being switched on by the detection of the light.Additionally or alternatively, the light-sensitive element may generatea photocurrent or a photovoltage sufficient for switching on theelectronics unit.

The medical system may further comprise at least one adhesive plasterfor attaching the electronics unit to a skin surface of a user. Theadhesive plaster may be attached directly or indirectly to theelectronics unit or to a part which, e.g., during insertion of theanalytical sensor, is connected to the electronics unit. The adhesiveplaster may be or may comprise an adhesive surface, e.g., an adhesivesurface of a rigid part or of a flexible bandage. The adhesive plaster,in an initial state of the medical system with the protective cap beingconnected to the housing, may be covered by at least one removableliner. The liner may be connected to the protective cap, e.g., directlyby attaching the liner or a part thereof such as a ribbon or a latch ofthe liner to the protective cap, or indirectly, e.g., by connecting theprotective cap and the liner by using a ribbon, a protrusion of theprotective cap or the like. By these means or other means, the linerthus may be configured for being pulled off from the adhesive plasterwhen the protective cap is removed from the housing.

The medical system may further comprise at least one insertion actuator.The term “insertion actuator” as used herein is a broad term and is tobe given its ordinary and customary meaning to a person of ordinaryskill in the art and is not to be limited to a special or customizedmeaning. The term specifically may refer, without limitation, to anarbitrary device which is configured for directly or indirectlyinserting at least one insertable element into a body tissue. Theinsertion actuator may comprise at least one mechanical device which isconfigured for driving forward the insertable element or the insertioncomponent such as the insertion cannula into the body tissue. Theinsertion actuator, as an example, may comprise at least one sliderconnected to the insertion component or the holder for the insertioncomponent and configured for performing a forward linear motion in aninsertion direction and, optionally, a backward linear motion in anopposite direction. As an example, the slider may be driven by at leastone spring element, which may be pre-tensioned or biased in the forwarddirection or in the backward direction. Additionally or alternatively,the slider may be connected to at least one actuation button which maybe pushed by the user, thereby driving the slider in the forwarddirection. The insertion actuator, thus, may be configured for drivingthe insertion component into the body tissue and, optionally, backwardsagain after insertion of the insertable analytical sensor. The backwardmotion, as an example, for retracting the insertion component such asthe insertion cannula from the body tissue, may be driven by a returnspring or by a motion inverter. The insertion actuation by the insertionactuator may further initiate or provide other actions, such as anassembly of components of the body mount, such as components providing ashell for the electronics unit, and/or an attachment of a body mount tothe skin of the user. Inserting actuators configured for driving aninsertion motion as known to the skilled person may also be used in thecontext of this disclosure. As an example, reference may be made to theactuators disclosed in the above-mentioned documents WO 2016/012482 A1,WO 2016/012497 A1 or WO 2017/037191 A1 and the prior art cited therein.These insertion actuators may also be used in the context of thisdisclosure, directly or with context-specific modifications. Generally,the insertion actuator may be configured for advancing the insertioncomponent after removal of the protective cap from the housing and forinserting the analytical sensor into the body tissue.

As indicated above, the medical system may comprise a body mount. Theterm “body mount” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the artand is not to be limited to a special or customized meaning. The termspecifically may refer, without limitation, to an analytical componentinteracting with the analytical sensor configured for being mounted tothe skin of the user. The body mount may comprise the adhesive plasterand a cradle attached to the adhesive plaster and configured forreceiving the electronics unit, as well as, fully or partially, theelectronics unit. Further, optionally, the body mount may comprise anupper shell covering the electronics unit, wherein, as an example, theupper shell may be connected to the cradle, thereby forming a shellfully or partially enclosing the electronics unit. The analyticalsensor, in an inserted state with the body mount attached to the skin,may protrude from a lower side of the electronics unit, through anopening in the cradle and an opening in the adhesive plaster, into thebody tissue.

In an initial state, before removing the protective cap from thehousing, the body mount may be received in the housing. Therein, thebody mount may be received in the housing in an assembled state or in adisassembled state, wherein, in the latter case, an assembly may takeplace during insertion or after insertion of the analytical sensor intothe body tissue. Thus, generally, the body mount may comprise at leastone cradle for attachment to the skin of the user and at least one uppershell, wherein the electronics unit is received in the upper shell. Thecradle and the upper shell may be disassembled before actuation of theinsertion actuator. The medical system, specifically the cradle and theupper shell, may be configured for being assembled when the insertionactuator is actuated. Thus, as an example, when the insertion actuatormoves forward towards the skin of the user, the adhesive plaster and/orthe cradle may reach the skin and, thereby, a forward movement of thesecomponents may be stopped, wherein the electronics unit with theanalytical sensor connected thereto and, optionally, the upper shellstill may move forward towards the skin. Thereby, firstly, theelectronics unit may be inserted into the cradle. Secondly, afterwards,the upper shell may be put on top and may be locked to the electronicsunit and/or to the cradle, thereby forming a casing or shell for theelectronics unit. Simultaneously, during the forward motion, theinsertion component may be driven into the body tissue, therebyinserting the analytical sensor into the body tissue. Afterwards, theinsertion component may be retracted from the body tissue, with theanalytical sensor remaining in the body tissue.

As outlined above, the insertion actuator specifically may comprise atleast one pushbutton. The pushbutton, as an example, may comprise alinearly slidable pushbutton which may be pushed in a linear direction,such as perpendicular to the skin of the user. The insertion actuator,specifically the pushbutton, may be comprised in the housing, may beattached to the housing or may be integrated into the housing. Asfurther outlined above, the insertion actuator further may be configuredfor retracting the insertion component from the body tissue afterinsertion of the analytical sensor.

The protective cap, in addition or as an alternative to one or more ofthe above-mentioned functions, may provide further functionality. Thus,as an example, the protective cap may also provide functions for keepingthe level of humidity within the closed medical system, before removalof the protective cap, low. Thus, specifically, the protective cap maycomprise a plurality of chambers at least partially filled with adesiccant such as silica gel. As an example, on one or more innersurfaces facing towards the housing, the protective cap may comprise oneor more separating walls protruding from the at least one in the surfaceinto an interior of the protective cap, thereby forming the chambers,which, as an example, may be open towards the housing. The chambers mayfully or partially be filled with the at least one desiccant.

As a further, additional or alternative measure for protecting theanalytical sensor and/or the electronics unit in the medical system fromhumidity, the medical system may further comprise at least one humidityseal received in between the protective cap and the housing. Thus, asoutlined above, the protective cap may overlap with the housing in anoverlap region, which may also provide the at least one guiding surface.Within this overlap region, at least one humidity seal may be provided,such as by providing O-ring and/or by providing a line of glue, such asa circumferential line. The humidity seal may be broken when theprotective cap is removed from the housing.

The medical system may further comprise at least one package. Thepackage specifically may be an airtight and/or a humidity-tight packagesuch as a blister pack. The remaining components of the medical systemmay be enclosed in the closed package, specifically in the blister pack.Thus, the housing, the preassembled functional module and the removableprotective cap connected to the housing may form a single, closed unitof the medical system which may be enclosed in the closed package, withthe preassembled functional module, e.g., preassembled by factoryassembly, enclosed in the housing with the protective cap attachedthereto. Thus, once the user opens the closed package, taking out theunit, the unit may be ready to use.

In a further aspect of this disclosure, a method of manufacturing amedical system, specifically of a medical system as disclosed above oras disclosed in further detail below, is proposed. The method comprisesthe steps disclosed in the following. The steps specifically may beperformed in the given order. Still, a different order is possible. Themethod may comprise additional steps which are not mentioned. It isfurther possible to perform one or more of the method steps repeatedly.Further, two or more of the method steps may be performed in a timelyoverlapping fashion or simultaneously.

The method steps comprised by the method of manufacturing the medicalsystem are:

-   -   i. providing a housing;    -   ii. preassembling a functional module, the preassembled        functional module comprising:        -   an analytical sensor for detecting at least one analyte in a            body fluid of a user;        -   an electronics unit electrically connected to the analytical            sensor; and        -   an insertion component for inserting the analytical sensor            into the body tissue;    -   iii. receiving the preassembled functional module in the        housing; and    -   iv. connecting at least one removable protective cap to the        housing, thereby covering the preassembled functional module.

As indicated above, the method specifically may be used formanufacturing the medical system as proposed therein, such as accordingto any one of the embodiments disclosed above and/or according to anyone of the embodiments disclosed in further detail below.

Further proposed is a method of using the medical system according tothis disclosure, such as the medical system according to any one of theembodiments disclosed above or according to any one of the embodimentsdisclosed in further detail below. The method may comprise the followingsteps, preferably in the given order. A different order, however, mayalso be feasible. Further, again, one, more than one or even all of themethod steps may be performed repeatedly. Further, two or more of themethod steps may also be performed fully or partially simultaneously.The method may comprise further steps.

The method comprises:

-   -   I. providing the medical system,    -   II. removing the protective cap from the housing,    -   III. placing the housing against the skin of the user, and    -   IV. inserting the analytical sensor into the body tissue of the        user.

Method step I. may also include removing a unit of the medical system,comprising the housing, the protective cap and the preassembledfunctional module, from a closed package, such as from a blister pack.

Method step II. may comprise a plurality of sub-steps, which may beinitiated by removing the protective cap from the housing. One or moreof the sub-steps disclosed in the following may be comprised. Thus, asindicated above, the steps may comprise switching on the electronicsunit. Additionally or alternatively, the step may comprise removing asterility cap from the insertion component. Additionally oralternatively, the step may also comprise breaking an indicator seal.Additionally or alternatively, the step may also comprise removing aliner from an adhesive plaster.

Method step III. may comprise attaching an adhesive plaster to the skinand, further, optionally, placing a cradle onto the skin and adheringthe cradle to the skin with the adhesive plaster.

Similarly, method step IV. may comprise one or more of the followingsub-steps. Thus, as an example, the method step may comprise the step ofinitiating the insertion by activating an insertion actuator, such as bypushing a pushbutton. The step may also comprise an assembly of a bodymount, e.g., by assembling the adhesive plaster, the cradle and theelectronics unit as well as, optionally, an upper shell to form a singleunit.

The medical system and the method according to this disclosure provide alarge number of advantages over known methods and devices. Thus,specifically, the above-mentioned technical challenges of knowninserting devices, specifically for continuous monitoring sensors, areaddressed.

Specifically, the medical system may provide for a fully disposablecontinuous monitoring system, such as a fully disposable continuousglucose monitoring system. The functional module may be preassembled,such that the body mount, the electronics unit and the analytical sensorare already in an assembled state. The functional module in combinationwith the housing and the removable protective cap may also form apreassembled module and may be delivered to the customer in such apreassembled fashion. Thus, no further assembling steps generally needsto be performed by the user. The preassembled module may comprise thehousing, the functional module and the protective cap. The protectivecap may combine different functionalities in one element. Suchfunctionalities may include one or more of ensuring a sterile and safeenvironment, providing a simple user handling for removal of theprotective cap, providing for a sterile barrier of the analytical sensorcompartment, initializing of medical system, providing fortamper-evident closure means such as the indicator seal or furtherfunctionalities. The protective cap specifically may ensure, in a simpleand cost efficient fashion, a high robustness, and easy systeminitialization, as well as easy handling steps, in one system element.The medical system may provide for a sensor system for monitoring ananalyte concentration, comprising an assembly of the analytical sensor,an inserter and an electronics unit. The analytical sensor, the inserterand the electronics unit may be preassembled prior to application of theanalytical sensor. This pre-assembly specifically may be a factorypre-assembly, prior to unpacking the system by a user. The assembly mayfurther comprise the protective cap which may fix the inserter, theanalytical sensor and the electronics unit in place and, upon removal ofthe protective cap, may allow for insertion of the analytical sensorinto subcutaneous tissue. as outlined above, the protective cap may bepart of an initialization concept for the medical system, e.g., by theelectronics unit comprising at least one photosensitive element whichdetects ambient light once the protective cap is removed, therebyinitiating the electronics unit in connection with the analyticalsensor. Additionally or alternatively, the protective cap mayincorporate guiding means for simpler user handling on removal of theprotective cap, e.g., via a screw that also may be used as seal.Additionally or alternatively, the protective cap may include atamper-evident closure, which may also aid as a barrier for liquid orhumidity.

Thus, the protective cap specifically may provide multiple functions andmultiple solutions for the technical challenges. Thus, as indicatedabove, by providing a protection against humidity, the protective capmay protect sensitive components of the analytical sensor, such as thesubstrate, enzymes or the like. Thereby, the storage lifetime may beincreased. No additional desiccant in an outer packaging, including therequirement for additional space, is generally required. The desiccantmay be placed in the protective cap, e.g., by placing the desiccantdirectly into the protective cap and/or by implementing one or morepackages of desiccant into the protective cap, e.g., by materialengagement such as gluing and/or by formfitting connection. The amountof desiccant may be adapted to the desired storage lifetime of themedical system.

The protective cap may further, as indicated above, be used as a switchfor switching on the electrical unit, such as the transmitter. Thus, asoutlined above, several functionalities and/or switching concepts may beimplemented. As an example, optical switches such as one or morephototransistors may be used, wherein, when removing the protective capfrom the housing, ambient light may switch on the electronics unit. Theprotective cap generally may be designed by using a light-tightmaterial, in order to avoid unintentionally switching on the electronicsunit and in order to provide a light barrier which is broken immediatelybefore use of the medical system by the user. An appropriate geometry ofthe protective cap may be chosen.

The protective cap may further provide mechanical protection. Thus, anadditional mechanical protection for the entire medical system isprovided. Thus, by appropriate and/or flexible design of the protectivecap or of parts thereof, the protective cap alone or in conjunction withthe housing may absorb or reduce mechanical influences and shocks. Thus,as an example, without the protective cap, the medical system may bedropped onto a sterility cap covering the insertion component such asthe insertion cannula and thereby inducing damages to the insertioncomponent. Without the protective cap, other constructive protectivemeasures would be required.

Further, as outlined above, the sterility cap and the removal of thesame impose further technical challenges onto typical medical systems.Due to the length of the insertion component, such as the length of theinsertion cannula, pulling off the sterility cap typically requires aminimum length of guiding, such as a minimum length of 10 mm, in orderto safely remove the sterility cap from the insertion component and inorder to avoid damaging of the insertion component by the sterility capduring removal. By connecting the sterility cap to the protective cap,the guiding of the sterility cap during removal may be increased andimproved. Thus, as an example, the protective cap may be guided by thehousing when removing the protective cap from the housing, wherein aguiding length or guiding distance increases the length of the insertioncomponent and/or the length of the protective cap. Thus, by thisincreased guiding, as an example, transversal movements may be possibleonly after the sterility cap has safely cleared the insertion componentsuch as the cannula.

The protective cap may further be used for preparing the body mount forattachment to the skin of the user. Thus, as outlined above, the removalof the protective cap from the housing may also be used for removing aliner from an adhesive plaster.

The protective cap may further be used in connection with an indicatorseal, such as the originality closure, and/or with a humidity barrier.Thus, in between the protective cap and the housing, the indicator sealmay be provided, such as by providing a visible adhesive tape whichclearly indicates whether the medical system has been opened and/ordamaged. The indicator seal may also provide an additional barrieragainst humidity and, thus, may render an additional package obsolete.Additionally or alternatively, a humidity barrier may be provided inbetween the protective cap and the housing or the pushbutton of theactuator.

Further, as outlined above, when removing the protective cap from thehousing, various movements are feasible. Thus, purely translationalmovements as well as combinations with rotational movements arefeasible. Further, the movement of the protective cap may be translatedinto an appropriate movement of the sterility cap. Thus, even if theprotective cap performs a purely translational movement, thistranslational movement may be translated into a rotational component ofthe sterility cap or vice versa. For transforming a movement of theprotective cap into a desired movement of the sterility cap, thesterility cap may be connected to the protective cap via one or moreguiding elements, such as one or more cam controls. Thereby, thesterility cap may be unlocked from one or more of the insertioncomponent, the electronics unit, the holder or the preassembledfunctional module, e.g., by a bayonet lock. Generally, by making use ofone or more of these options, the geometry of the medical system, suchas the geometry of the insertion actuator, may be separated from thegeometry of other components of the medical system and, generally, maybe chosen freely. The insertion actuator not necessarily has to have around cross-section, and the electronics unit may be optimized onto asmall area. Generally, the geometry may be chosen independent from thefunctions of the components, such as of the transmitter.

Summarizing and without excluding further possible embodiments, thefollowing embodiments may be envisaged:

Embodiment 1: A medical system, comprising:

-   -   a. a housing;    -   b. a preassembled functional module received in the housing, the        preassembled functional module comprising:        -   b1. an analytical sensor for detecting at least one analyte            in a body fluid of a user;        -   b2. an electronics unit electrically connected to the            analytical sensor; and        -   b3. an insertion component for inserting the analytical            sensor into a body tissue of the user; and    -   c. at least one removable protective cap connected to the        housing, covering the preassembled functional module.

Embodiment 2: The medical system according to the preceding embodiment,wherein the housing comprises at least one receptacle for receiving theelectronics unit, the receptacle being open towards an end of thehousing covered by the protective cap.

Embodiment 3: The medical system according to any one of the precedingembodiments, wherein the electronics unit comprises at least one of: ameasurement device for providing electrochemical measurement values,specifically at least one of an amperometric or a potentiostaticmeasurement device; a transmitter for transmitting measurement values toat least one external receiver; an integrated data storage device; anintegrated battery.

Embodiment 4: The medical system according to any one of the precedingembodiments, wherein the analytical sensor is fixedly electricallyconnected to the analytical sensor.

Embodiment 5: The medical system according to any one of the precedingembodiments, wherein the analytical sensor is an electrochemicalanalytical sensor, having at least one working electrode and at leastone further electrode selected from the group consisting of a counterelectrode and a reference electrode, wherein the at least one workingelectrode and the at least one further electrode are connected to theelectronics unit via at least two electrical leads.

Embodiment 6: The medical system according to any one of the precedingembodiments, wherein the preassembled functional module furthercomprises at least one sterility cap at least partially surrounding theinsertion component.

Embodiment 7: The medical system according to the preceding embodiment,wherein the insertion component comprises at least one insertioncannula, with the analytical sensor partially received therein.

Embodiment 8: The medical system according to the preceding embodiment,wherein the insertion component further comprises at least one holderfor the insertion cannula, wherein the holder, the insertion cannula andthe sterility cap form components of a sterile container for theanalytical sensor.

Embodiment 9: The medical system according to any one of the threepreceding embodiments, wherein the protective cap is removable from thehousing by pulling off the protective cap from the housing, wherein thehousing comprises at least one guiding surface for guiding theprotective cap during pulling off the protective cap, specifically acircumferential guiding surface.

Embodiment 10: The medical system according to the preceding embodiment,wherein the sterility cap is connected to the protective cap, whereinthe sterility cap is configured for being pulled off from the insertioncomponent when the protective cap is pulled off from the housing.

Embodiment 11: The medical system according to the preceding embodiment,wherein the preassembled functional module comprises at least oneguiding surface for guiding the sterility cap during pulling off thesterility cap from the insertion component.

Embodiment 12: The medical system according to the preceding embodiment,wherein a length of the guiding surface of the housing exceeds a lengthof the guiding surface for the sterility cap, specifically by at least afactor of 2, more specifically by at least a factor of 5 or by at leasta factor of 10.

Embodiment 13: The medical system according to any one of the threepreceding embodiments, wherein a length of the guiding surface of thehousing exceeds a length of the sterility cap, specifically such thatthe sterility cap is fully pulled off from the insertion componentbefore the guiding by the guiding surface of the housing ends when theprotective cap is pulled off from the housing.

Embodiment 14: The medical system according to any one of the fourpreceding embodiments, wherein the guiding surface of the housingprovides at least one movement selected from the group consisting of: atranslational movement of the protective cap and the sterility cap whenthe protective cap is pulled off from the housing; a rotational movementof the protective cap and the sterility cap when the protective cap ispulled off from the housing; both a translational and a rotationalmovement of the protective cap and the sterility cap when the protectivecap is pulled off from the housing.

Embodiment 15: The medical system according to the preceding embodiment,wherein the guiding surface of the housing provides at least arotational component when the protective cap is pulled off from thehousing, wherein the sterility cap is connected to the preassembledfunctional module by at least one bayonet connection, wherein, by therotational component, the bayonet connection is untightened and thesterility cap is removable from the preassembled functional module.

Embodiment 16: The medical system according to any one of the precedingembodiments, further comprising at least one indicator seal connected tothe protective cap and the housing, wherein the indicator seal isconfigured to be broken when the protective cap is removed from thehousing.

Embodiment 17: The medical system according to the preceding embodiment,wherein the indicator seal comprises one of a sealing foil and a sealingtape.

Embodiment 18: The medical system according to any one of the twopreceding embodiments, wherein the indicator seal is light-tight.

Embodiment 19: The medical system according to any one of the precedingembodiments, wherein the medical system is configured such that theelectronics unit is switched on when the protective cap is removed fromthe housing.

Embodiment 20: The medical system according to the preceding embodiment,wherein the electronics unit is switched on by at least one switchingmechanism selected from the group consisting of: a mechanical switchconnected to the cap, wherein the mechanical switch is switched on whenthe protective cap is removed from the housing; a light-sensitiveswitch, wherein the light-sensitive switch is switched on by ambientlight when the protective cap is removed from the housing; a linercovering a battery of the electronics unit, wherein the liner is pulledoff when the protective cap is removed from the housing.

Embodiment 21: The medical system according to any one of the precedingembodiments, wherein the medical system further comprises at least oneadhesive plaster for attaching the electronics unit to a skin surface ofa user, wherein the adhesive plaster is covered by a liner, wherein theliner is connected to the protective cap, wherein the liner isconfigured for being pulled off from the adhesive plaster when theprotective cap is removed from the housing.

Embodiment 22: The medical system according to any one of the precedingembodiments, wherein the medical system further comprises at least oneinsertion actuator, wherein the insertion actuator is configured foradvancing the insertion component after removal of the protective capfrom the housing and for inserting the analytical sensor into the bodytissue.

Embodiment 23: The medical system according to the preceding embodiment,wherein the medical system further comprises a body mount received inthe housing, wherein the electronics unit is at least partiallycomprised in the body mount.

Embodiment 24: The medical system according to the preceding embodiment,wherein the body mount comprises at least one cradle for attachment tothe skin of the user and at least one upper shell, wherein theelectronics unit is received in the upper shell, wherein the cradle andthe upper shell are disassembled before actuation of the insertionactuator and wherein the cradle and the upper shell are configured forbeing assembled when the insertion actuator is actuated.

Embodiment 25: The medical system according to any one of the threepreceding embodiments, wherein the insertion actuator comprises at leastone pushbutton.

Embodiment 26: The medical system according to any one of the fourpreceding embodiments, wherein the insertion actuator is configured forretracting the insertion component from the body tissue after insertionof the analytical sensor.

Embodiment 27: The medical system according to any one of the precedingembodiments, wherein the protective cap comprises a plurality ofchambers at least partially filled with a desiccant.

Embodiment 28: The medical system according to any one of the precedingembodiments, wherein the medical system further comprises at least onehumidity seal received in between the protective cap and the housing.

Embodiment 29: The medical system according to any one of the precedingembodiments, wherein the medical system is contained in a closedpackage, specifically in a blister pack.

Embodiment 30: A method of manufacturing a medical system, comprising:

-   -   i. providing a housing;    -   ii. preassembling a functional module, the preassembled        functional module comprising:        -   an analytical sensor for detecting at least one analyte in a            body fluid of a user;        -   an electronics unit electrically connected to the analytical            sensor; and        -   an insertion component for inserting the analytical sensor            into the body tissue;    -   iii. receiving the preassembled functional module in the        housing; and    -   iv. connecting at least one removable protective cap to the        housing, thereby covering the preassembled functional module.

Embodiment 31: The method according to the preceding embodiment, whereinthe medical system is a medical system according to any one of thepreceding embodiments referring to a medical system.

BRIEF DESCRIPTION OF THE FIGURE

The above-mentioned aspects of exemplary embodiments will become moreapparent and will be better understood by reference to the followingdescription of the embodiments taken in conjunction with theaccompanying drawings, wherein:

FIG. 1 shows a cross-sectional view of an embodiment of a medicalsystem.

DESCRIPTION

The embodiments described below are not intended to be exhaustive or tolimit the invention to the precise forms disclosed in the followingdetailed description. Rather, the embodiments are chosen and describedso that others skilled in the art may appreciate and understand theprinciples and practices of this disclosure.

In FIG. 1 , a cross-sectional view of an embodiment of a medical system110 is shown. The medical system comprises a housing 112 which, as anexample, may be made of a plastic material. The housing 112 may compriseone component or a plurality of components.

Within the housing 112, in this exemplary embodiment, an insertionactuator 114 is comprised, which, as an example, may comprise apushbutton 116. As an example for potential details of the insertionactuator, reference may be made to the above-mentioned prior artdocuments, such as to WO 2017/037191 A1 as well as the prior art citedtherein. It shall be noted, however, that other insertion mechanisms arefeasible.

Further received within the housing 112 is a preassembled functionalmodule 118. Thus, as an example, the housing 112 may comprise areceptacle 122 in which the preassembled functional module 118 isreceived. The preassembled functional module 118 comprises an analyticalsensor 120 which is not visible in this FIGURE and which is receivedwithin a sterility cap 124. The preassembled functional module 118further comprises at least one electronics unit 126, such as at leastone transmitter 128. Further, the preassembled functional module 118comprises at least one insertion component 130, which also is notvisible in this FIGURE. The insertion component 130, as an example, maycomprise at least one insertion cannula 132, e.g., an insertion cannula132 having a slot with the analytical sensor 120 received therein.

The medical system 110 further comprises at least one protective cap134. The protective cap 134, in the closed state as shown in FIG. 1 ,which is the state before use of the medical system 110, is connected tothe housing 112. Thus, as an example, the protective cap 134 may overlapwith the housing 112 in an overlap region 136. Thus, a circumferentialrim 138 of the protective cap 134 may snugly fit on a circumferentialguiding surface 140 on an upper outer side of the housing 112. Theprotective cap 134, for disconnecting from the housing 112, may bepulled off from the housing 112, wherein the guiding surface 140 mayhave a length L in the direction of pulling off the protective cap 134.

When pulling off the protective cap 134 from the housing 112, variousfunctions may be initiated. Thus, as an example, the sterility cap 124may be connected to the protective cap 134 by a connection 142. Thus,when pulling off the protective cap 134 from the housing 112, thesterility cap 124 may be pulled off from the insertion component 130.Therein, a length 1 of the sterility cap 124 may be smaller than theguiding length L, such that the sterility cap 124 fully clears theinsertion component 130 before the guiding of the protective cap 134 bythe guiding surface 140 ends. Thereby, a misplacement of the sterilitycap 124 in relation to the insertion component 130 is avoided, whichmight lead to a damaging of the insertion component 130. Consequently,the connection between the sterility cap 124 and the protective cap 134may lead to a safe removal of the sterility cap 124 from the insertioncomponent 130.

The sterility cap 124, the insertion component 130 and a holder 144 forthe insertion component 130 may form a miniaturized sterile container146 for the analytical sensor 120. This sterile container 146 may bedisassembled, by removing the sterility cap 124, when the protective cap134 is removed from the housing 112.

The medical system 110 may further comprise a body mount 148. The bodymount 148, which may also be placed in the receptacle 122, may contain acradle 150 which may be placed against the skin of the user once theprotective cap 134 is removed. The body mount 148 may further comprisean adhesive plaster 152 on top of the cradle 150, for adhering thecradle 150 onto the skin. The adhesive plaster 152 may be protected by aliner 154 which, e.g., via one or more protrusions 156 of the protectivecap 134, may be connected to the protective cap 134. Thus, when theprotective cap 134 is removed from the housing 112, the protective cap134 may also remove the liner 154 from the adhesive plaster 152.

The cradle 150 may be configured for receiving the electronics unit 126.Thus, the electronics unit 126 may also fully or partially be part ofthe body mount 148. The electronics unit 126, in this exemplaryembodiment, may be received in an upper shell 158, which may also formpart of the body mount 148 and which may interact with the cradle 150for providing a cover for the electronics unit 126.

The medical system 110 may further comprise at least one desiccant 160.The desiccant 160 may be comprised in the protective cap 134,specifically in a plurality of chambers 162 provided by the protectivecap 134.

The medical system 110 may further comprise at least one indicator seal164, such as at least one clearly visible tape, at a transition betweenthe protective cap 134 and the housing 112. The indicator seal 164,firstly, may clearly indicate whether the medical system 110 has beenused or not and may be broken when removing the protective cap 134 fromthe housing 112. The indicator seal 164 may provide furtherfunctionality, such as by providing a humidity barrier and by preventingor reducing the ingression of humidity into the protective cap 134and/or into the housing 112. Further, the indicator seal 164 may providea light barrier and may be rendered light-tight. This is specificallyuseful in connection with an optical switching mechanism.

Thus, the electronics unit 126 may comprise an optical switch, such asan optical switch having a photodiode or a phototransistor. Theprotective cap 134 may be light-tight. When removing the protective cap134 from the housing 112 for the first time, the photosensitive elementof the electronics unit 126 may register the ambient light and mayswitch on the electronics unit 126. Other switches connected to themovement and removal of the protective cap 134 are feasible, such asmechanical switches. Thus, generally, the electronics unit 126 may beconfigured for being switched on when the protective cap 134 is removedfrom the housing 112.

For providing further humidity protection, at least one humidity seal166 may be provided in between the protective cap 134 and the housing.Thus, as an example, one or more lines of glue may be provided on theguiding surface 140.

For use of the medical system 110 according to FIG. 1 , the protectivecap 134 may be removed from the housing 112. Thereby, as outlined above,the sterility cap 124 may be removed from the insertion component 130.The removal of the sterility cap 124 may take place by purelytranslational movement, such as in an axial direction in FIG. 1 .Additionally or alternatively, the removal of the sterility cap 124 mayalso imply a rotational movement, e.g., by transforming a translationalmovement of the protective cap 134 into a rotational movement of thesterility cap 124. Thus, as an example, a connection between theprotective cap 134 and the sterility cap 124 may provide for anappropriate motion transformation, e.g., by providing one or more cams.

Further, as outlined above, by removal of the protective cap 134, theliner 154 may be removed, and the electronics unit 126 may be switchedon. Subsequent to the removal of the protective cap 134, the housing 112may be placed onto the desired skin side. Thereby, by the adhesiveplaster 152, the cradle 150 is adhered to the skin.

Subsequently, by pushing the push button 116, the insertion component130, e.g., the insertion cannula 132, is driven into the body tissue,thereby placing the analytical sensor 120 into the body tissue. Once theinsertion has taken place, the insertion component 130 is retracted fromthe body tissue, back into the housing 112, remaining therein andpreventing injuries. Further, during the insertion motion initiated bythe insertion actuator 114, the body mount 148 is assembled. Thus, theupper shell 158 is connected to the cradle 150, safely placing theelectronics unit 126 in between. It shall be noted, however, that theanalytical sensor 120 is already electrically connected to theelectronics unit 126 in the unused state as shown in FIG. 1 , since thefunctional module 118 is preassembled. Thus, during insertion, noelectrical connection between the analytical sensor 120 and theelectronics unit 126 has to take place, thereby reducing the complexityof the insertion motion and reducing the risk of electrical failureduring the connection. Thus, the electronics unit 126, with theanalytical sensor 120 fixedly connected thereto, may fully be designedas a disposable unit, without reusable parts. By providing a battery andby providing a switching mechanism, e.g., triggered by the removal ofthe protective cap 134, the number of handling steps may significantlybe reduced, leading to a simplified operating procedure which can bemanaged even by elderly people and children.

After insertion of the analytical sensor 120 into the body tissue andplacement of the body mount 148 onto the skin, the remaining parts ofthe medical system 110, specifically the housing 112 and the insertionactuator 114, may be removed and may be disposed of No further handlingsteps are required for the user, e.g., no further handling steps such asconnecting electronic components to the analytical sensor 120 and/or thebody mount 148 or the electronics unit 126. Thus, after performing theabove-mentioned steps, without further steps, the analytical sensor 120and the electronics unit 126 may provide measurement values. Themeasurement values, as an example, may be transmitted wirelessly to areceiver, such as a medical data management system.

While exemplary embodiments have been disclosed hereinabove, the presentinvention is not limited to the disclosed embodiments. Instead, thisapplication is intended to cover any variations, uses, or adaptations ofthis disclosure using its general principles. Further, this applicationis intended to cover such departures from the present disclosure as comewithin known or customary practice in the art to which this inventionpertains and which fall within the limits of the appended claims.

LIST OF REFERENCE NUMBERS

-   -   110 medical system    -   112 Housing    -   114 insertion actuator    -   116 Pushbutton    -   118 preassembled functional module    -   120 analytical sensor    -   122 Receptacle    -   124 sterility cap    -   126 electronics unit    -   128 Transmitter    -   130 insertion component    -   132 insertion cannula    -   134 protective cap    -   136 overlap region    -   138 Rim    -   140 guiding surface    -   142 Connection    -   144 Holder    -   146 sterile container    -   148 body mount    -   150 Cradle    -   152 adhesive plaster    -   154 Liner    -   156 Protrusion    -   158 upper shell    -   160 Desiccant    -   162 Chamber    -   164 indicator seal    -   166 humidity seal

What is claimed is:
 1. A method of manufacturing a medical system,comprising: (a) providing a housing; (b) providing a pre-assembledmodule having the following components: an electronics unit electricallyconnected to an analyte sensor, an insertion component configured forinserting the analyte sensor into body tissue of a user, and a sterilecontainer containing at least part of the analyte sensor and at leastpart of the insertion component in a sterile environment, the sterilecontainer comprising a sterility cap that seals off the sterileenvironment, (c) connecting the housing to a protective cap and therebyenclosing the preassembled module; and (d) configuring the medicalsystem so that (i) removing the protective cap from the housing removesthe sterility cap from the sterile container and exposes the insertioncomponent for insertion into the body tissue, and (ii) the housingcooperates with the protective cap during the removing of the protectivecap from the housing to guide the sterility cap axially until thesterility cap clears the insertion component, whereby the risk ofdamaging the insertion component during the removal of the sterility capis reduced.
 2. The method according to claim 1, wherein the step ofproviding the housing comprises providing the housing with threads thatmate with complementary threads provided on the protective cap.
 3. Themethod according to claim 2, wherein step (c) comprises screwing the capand the housing together.
 4. The method according to claim 3, whereinduring step (c) the protective cap performs a translational movement inaddition to the screwing of the cap and the housing together.
 5. Themethod according to claim 1, wherein the medical system is configuredsuch that removing the protective cap from the housing rotates thesterility cap relative to the remainder of the sterile container.
 6. Themethod according to claim 5, wherein the medical system is configuredsuch that unscrewing the protective cap from the housing rotates thesterility cap relative to the remainder of the sterile container.
 7. Themethod according to claim 6, wherein the rotating of the sterility capuntightens a bayonet connection of the sterility cap such that thesterility cap is removable from the module.
 8. The method according toclaim 1, further comprising connecting an indicator seal to the housingand to the protective cap.
 9. The method according to claim 1, furthercomprising connecting the electronics unit to the analyte sensor beforestep (c).
 10. The method according to claim 1, further comprisingreceiving the module in a receptacle in the housing before step (c). 11.The method according to claim 1, further comprising fixedly connectingthe sterility cap to the module before step (c).
 12. The methodaccording to claim 1, wherein step (c) comprises connecting the housingto the protective cap by a form-fit, a force fit or a threadedconnection.
 13. The method according to claim 12, wherein step (c)comprises connecting the housing to the protective cap by a threadedconnection.
 14. The method according to claim 1, wherein step (c)comprises providing that the protective cap overlaps the housing by alength L after the connection of the housing and the protective cap iscompleted.
 15. The method according to claim 14, wherein step (d)comprises configuring the medical system so that the housing cooperateswith the protective cap over the length L during the removing of theprotective cap from the housing to guide the sterility cap axially. 16.The method of claim 15, further comprising providing the pre-assembledmodule with a guiding surface that is configured to guide the sterilitycap during the removing of the protective cap from the housing.
 17. Themethod according to claim 14, wherein step (d) comprises configuring themedical system so that an outer surface of the housing cooperates withan inner surface of the protective cap over the length L during removalof the protective cap from the housing.
 18. The method according toclaim 17, wherein the housing and the protective cap are configured sothat the outer surface and the inner surface face each other.
 19. Themethod according to claim 1, further comprising providing an adhesiveconfigured for attaching the electronics unit to a skin surface of auser.
 20. The method according to claim 1, further comprising, beforestep (b), pre-assembling the preassembled module.
 21. The methodaccording to claim 20, wherein the pre-assembling includes electricallyconnecting the analyte sensor with the electronics unit.
 22. The methodaccording to claim 20, further comprising providing the insertioncomponent as an insertion cannula, wherein the pre-assembling includesreceiving the analyte sensor at least partially in the insertioncannula.